Should or Should not Gardasil be Mandatory for Sixth-grade Girls?

13 Oct 2016—Government and Law Essays

The human papillomavirus (HPV) is a sexually transmitted virus that may cause a number of illnesses, one of which is cervical cancer that inflicts 12,000 women and kills 3,700 women every year (Senay, 2007; Allen, March 2, 2007). According to Dr. Emily Senay (2007), 1 out of 4 women have HPV, and in the age group of 20-24, 45% of women have the virus.While the different states discuss the possibility of including Gardasil in the list of school vaccines, the only existing vaccine against four of the hundreds of types of HPVs, Texas became a trailblazer by being the first state to issue an executive order requiring the vaccine to be a requirement for sixth-grade girls (with the possibility of opting out based on religious or philosophical reasons (Allen, February 8, 2007). Faced with the on-going discussions country-wide on whether or not Merck’s Gardasil should be compulsory for a certain slice of the population, this paper will attempt to look at both sides of the issue. Ultimately, this paper would show that the executive order of Texas’ governor is correct, that Gardasil (or an equally effective vaccine in the future) should be obligatory for grade six girls. To even go one step further, the vaccine ought to be obligatory not only for grade six girls but even to grade six boys.

This argumentative essay will have four parts: a short discussion on the existing HPV vaccine; an exposition of the arguments against mandating of the HPV vaccine; an exposition of the arguments for the mandating of the HPV vaccine; and a conclusion stating why mandating of the vaccine makes more sense than not mandating it to grade six girls and boys. Gardasil, an HPV Vaccine

The huge pharmaceutical company, Merck, came out with Gardasil, the world’s first HPV vaccine last year, and was granted a license by the Food and Drug Administration for use of women ages 9-26 mid of 2006 (Guardian Unlimited, 2006). This new vaccine is intended to protect against four types of HPV’s, types 6, 11, 16, and 18. These HPV types account for 70% of cervical cancer cases and 90% of genital wart cases. (Medical News Today, 2006). As such, the vaccine could give 100% protection against diseases caused by these four HPV strains. In general, Gardasil is meant to protect women against the following diseases: cervical cancer, genital warts, cervical adenocarcinoma, cervical intraepithelial neoplasia, vulvar intraepithelial neoplasia, and vaginal intraepithelial neoplasia (Merck, 2007, p. 7).

Aside from its obvious beneficial effects on women, men may also benefit from this vaccine. According to gynecologic oncology Professor Bradley Monk, men may also benefit from this vaccine by protecting them against genital warts, as well as making them less prone from being carriers of the said virus strains.

This new vaccine was clinically tried on 25,000 patients, 5% of which were pre-teen girls (Allen, February 8, 2007). Gardasil proved to be safe and could be administered along with hepatitis B vaccine, but has not been tested concomitantly with other types of vaccines (Merck, 2007, p. 8). It proved to be efficient even with or alongside contraceptives; nevertheless it has not been tested or evaluated for its “potential to cause carcinogenicity or genotoxicity” (Merck, 2007, p. 8). Clinical trials of the vaccine on pregnant women are also wanting. Nevertheless, the vaccine proved not only efficacious but most especially safe, as could be seen from the Merck report (2007) on Gardasil’s clinical trials. The trials did not report on gross unwanted effects of the vaccine, aside from the minor injection-site adverse experiences such as mild and moderate pain and swelling (p. 12).

The vaccine is administered intramuscularly in three separate 0.5 ml doses. The schedule for its administration is as follows: elected date; 2 months after the first dose; and 6 months after the first dose (Merck, 2007, p. 13).

As of the present time, since Gardasil just came out of the market, phase IV clinical trials are wanting. Phase IV trials are given after a drug has been granted a license to further test on drug side-effects and safety; long-term risks and benefits; and the performance of the drug once it is administered on a wider population compared to the original clinical trial population (Cancer Research UK, 2007). There are obviously other things that this vaccine ought to be tested on, such as a fuller account of the effect of the vaccine on women who already have HPV prior to the administration of the vaccine, i.e., a testing on the vaccine’s possible therapeutic effects; an extension of the clinical trials on older women (Susman, 2005); the exact efficacy period of the vaccine; among many other things.

GlaxoSmithKline will also come out with its own version of HPV vaccine similar to Gardasil sometime soon. This might prove to be a good thing not only to give people choices; but also to balance out on HPV vaccine prices.

Why the HPV Vaccine Should Not Be Mandatory

A number of reasons have been put forth by anti-mandating proponents.

Some of the reasons are as follows:

From the religious camp, some say that making the HPV Vaccine mandatory to grade-six girls undermines parental responsibility on the issue of sexuality (Catholic News Agency, 2007). Parents are largely responsible for their children who are in the age of minority. The instilling of the necessary values for the girls not to engage in premarital sex is a parental right and responsibility; the taking care of the welfare of the children’s well-being is autonomously the parents’, and only secondarily society’s. This is the very reason why parents have the right to opt their children out of mandatory vaccines due to religious or philosophical reasons, parents have the primary rights over their children, and whether or not their grade-six girls should get a vaccine against a sexually-transmitted disease, a disease that the child would probably not get if only the right values are instilled early, should rest on the parents, not in the state. As such, Gardasil should not be mandatory but only optional.

Some religious groups also say that making the HPV Vaccine obligatory to grade-six girls promotes promiscuity. It might be true that Gardasil does not directly cause sexual promiscuity; nevertheless, people who have immunity against certain diseases are expected to act with less precaution compared to those who are not protected against such diseases. In one way or another, the absence of a vaccine acts as a sort of a deterrence against promiscuous sex. To remove such a deterrence is to further widen the doors towards sexual promiscuity of even the pre-teen girls. It must be kept in mind that injecting these pre-teen girls with the vaccine heightens their awareness on what they are immune to. In the same way that a person immune from food poisoning would likely be careless with the food that he/she eats, a young girl who is immune from HPV would likely engage in premarital sex, since the pleasure could be experienced with fewer risks. The best way to reduce cervical cancer (and the other diseases brought about by HPV) is not to make HPV vaccine mandatory, but to return to the values of chastity and prudence. What is needed is a moral revolution, not a patch up solution to a deeper problem.

Aside from the religious camp, there are also other camps that resist the mandating of Gardasil to grade-six girls. A number of proponents, including Jon Abramson, Chairman of the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices, think that mandatory HPV vaccination is just too soon (Allen, March 2, 2007). Gardasil has just been tested on 20,000 women. As such, such seems to be a small number compared to the millions of girls who will get the vaccine once it gets mandatory. We know for a fact that drugs may have unwarranted effects once it has been applied to a bigger population. Offering a vaccine of this sort as an option to women would definitely increase the vaccine’s exposure, but mandating it is a different story. Mandating it is somewhat “forcing” the vaccine to a portion of the population, a vaccine whose phase IV testing is far from being accomplished. This is outright recklessness that may affect all present-day grade-six girls in ways that are yet unknown.

What is more alarming is the poor number of girls on whom the clinical testing of the vaccine has been done. The vaccine was tested on 1,500 girls, and it is proposed to be mandated on “all” the grade-six girls in America. Research ethics will tell us that such is an unwarranted move. The small number of girls on whom the vaccine was tested on could hardly be considered conclusive, and as we know, pediatrics has its special considerations. An extensive testing ought to be done to a bigger population of grade-six girls for the pediatrics arm of the clinical testing to even be valid.

There are also camps who oppose such a vaccine because illnesses that result from recklessness and lack of responsibility do not deserve public money. In a Dutch Congress record, H.M. Dupuis argued that there are circumstances when people could be excluded from health care facilities (Dupuis in Beaufort, 1999, p. 108). Such would be the case of a drunk driver who encountered an accident who may have grabbed scarce medical resources from an old woman who has long been scheduled to undergo some sensitive surgery, if medical doctors are imprudent enough to give the resources to the drunk driver instead to the woman. This may similarly be the case of women with HPV. These women, especially those in the age of majority, acquired the virus through their own volition. HPV could not have been transmitted without the volition to engage in sex. This is far different from illnesses such as polio, mumps, measles, rubella or tuberculosis where transmission is highly involuntary. Such illnesses could easily be justified to warrant public money on them. The voluntariness of HPV (and the illnesses that issue from the virus) stops it from deserving the additional funds that the government has to provide if the HPV vaccine is to be mandatory.

Then comes the economic consideration of public spending. Gardasil costs $360 per individual. Along with this expense is the present federal cut on vaccine-purchasing aid. If we are to be realistic about it, states already find it difficult to pay for hepatitis B and pneumonia vaccines (Allen, March 2, 2007). It is easy to see that additional spending for an expensive obligatory vaccine will put too much financial strain on the country, most especially on individual states.

Why the HPV Vaccine Should be Mandatory

The HPV vaccine should be mandatory for grade six girls because of the following reasons:

The term “public health” was defined by M. Rothstein (in Verweij and Dawson, forthcoming, p. 3) as

…government intervention…that involves public officials taking appropriate measures pursuant to specific legal authority…to protect the health of the public…The key element in public health is the role of the government—its power and obligation to invoke mandatory or coercive measures to eliminate a threat to the public’s health.

Given this widely accepted definition of public, the only thing that ought to be determined is if HPV poses a threat to the public’s health, and by public here we refer to the aggregate, the mass of people who do not have faces but may all or impartially benefit from public health measures. If we could prove that HPV poses a public threat, then the government ought to exert coercive and mandatory measures to make sure that the threat is eliminated.

The number of women affected by HPV could easily be considered an epidemic. If 1 out of 2 young adults have it (i.e., 20-24 year old women), and if the chances of women in other age brackets to get it is 25%, then HPV infection has obviously reached an alarming rate that epidemiologists ought to be alarmed. If the government would just be gender blind about it, then the government could easily see that something has to be done as soon as possible, that indeed, a threat to the public’s health exists, and hence, the government must exert coercive measures to eliminate the threat. This could be done by making Gardasil mandatory, at the very least, to grade-six female students.

Another argument that could be used to defend the mandating of the vaccine would be the argument from the concept of herd protection. Herd protection refers to the protection that the non-vaccinated get “from exposure to the disease just because of the existence of high rates of vaccination for that disease in the population as a whole” (Dawson, forthcoming, p. 2). This is the reason why, even if one person carrying the polio virus enters the United States, chances are the virus would not get so far. This is because most of the population are vaccinated such that the small number of people who might not have the vaccine are protected by the herd, i.e., by those who are vaccinated. This is the same principle as quarantine. Now, this herd protection could only be achieved if a very good number of the population is vaccinated. HPV, given its epidemiological status, could only be totally eliminated and not pose any threat if most of the population are immune to it. This could be done only by making HPV vaccine mandatory, not only to sixth-grade girls, but also to sixth-grade boys who are not only susceptible to genital warts but most specially act as hosts to the virus without the immunity. This would ensure that eventually, the American population would be immune from the virus.

The argument from the very definition of public health deontologically makes the government obliged to act on HPV soon. This could only be done if coercive measures are undertaken to address the issue, concretely, by making the vaccine mandatory to both sixth-grade males and females. The government ought to act towards the achievement of herd protection against this virus to eliminate a real threat to the female population of America.

The argument that the mandating of the vaccine undermines parental responsibility neglects the real threat posed by the virus. Once an infection reaches epidemiological levels, the issue ceases to be a private matter and clearly becomes a public issue that ought to be addressed with urgency. The fact that 1 out 2 young adults have it does not give so much time for legislators to think and dilly-dally. A clinically proven vaccine is already out and as such, all measures would have to be put to ensure that this effective drug be used by Americans who are under attack by this malicious virus. The absence of Phase IV testing applies to all new drugs and such should not stop the government from mandating a highly effective and unharmful drug to the American population.